Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device

NCT02018172 | Terminated

• 1 other identifier: 000122
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.

Conditions

Growth Hormone Deficiency; Turner's Syndrome

Outcome Measures

Primary Outcomes (1)

• Rate of overall treatment adherence

  Ratio between actual duration of administration and total duration recommended by physician

  Up to 18 months

Study Arms (1)

Zomacton® treatment with Zomajet® Vision X device

Drug: somatropin

Interventions

somatropin DRUG

Also known as: Zomacton®

Zomacton® treatment with Zomajet® Vision X device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a growth hormone deficiency or Turner's syndrome.

You may qualify if:

• Patient with growth hormone deficiency,
• Diagnosis of growth hormone deficiency proven by appropriate exploration
• Size ≤ -2 Standard Deviation (SD) according to the French references
• Growth velocity in the previous year inferior to the normal for age (-1SD) or \< 4cm/year
• Growth deficiency due to Turner's syndrome
• Turner's syndrome confirmed by a karyotype
• Patient's size ≤ -2 SD according to the French references
• Bone age \< 12 years
• Patient who require a minimum of 18 months of treatment.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Hôpital des Enfants, CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Dwarfism, Pituitary; Turner Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

FR (1)